Voluntary Recalls

Overview of Voluntary Recalls

A recall may be undertaken voluntarily and at any time by manufacturers or distributors. While this is the most common occurrence, FDA can also request a recall, as an alternative to court action. FDA recall requests are used sparingly, and are directed to the firm that has primary responsibility for the manufacture and marketing of the product that is to be recalled.

FDA offers guidance for the planning, initiation, and implementation of voluntary recalls of regulated products. FDA also describe which aspects of voluntary recalls they consider crucial:

• Training of personnel for relevant recall duties.
• Specific recall initiation procedures.
• Thorough and organized records, especially product codes and distribution records.
• Procedures to identify potential problems investigate, and address them, including a recall.
• A recall communication plan to notify other firms in the distribution chain, FDA, and the public.
• Working cooperatively with FDA throughout the recall.

Anyone involved in quality control, supply chain, or regulatory affairs of FDA-regulated products should review FDA’s latest draft guidance document on voluntary recalls. This addresses how certain mandatory requirements relating to recalls (e.g. mandatory reporting requirements) and other FDA recall guidance documents (e.g. FDA’s final guidance on Public Warning and Notification of Recalls) should influence a company’s recall plans.

FDA has increasingly emphasized recalls as “a cornerstone” of its consumer protection mission, and FDA has issued multiple recall guidance documents in recent years, which complement FDA’s older recall guidance.  FDA has also more quickly posted new recalls to their publicly available Enforcement Reports, and established the FDA Strategic Coordinated Oversight of Recall Execution (SCORE) team to assist with difficult recalls

FDA will likely continue to issue additional guidance about voluntary recalls, such as including best-practices templates that firms can adopt and modify, guidance on what circumstances FDA believes do not warrant classification as a recall, and more specific guidance about how FDA classifies recalls. This will allow companies and the public to better prepare for and understand recalls. FDAImports has the know-how to help create plans to prevent or initiate a recall smoothly.